TPLC - Total Product Life Cycle

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Device	prosthesis, mitral valve, percutaneously delivered
Definition	These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Product Code	NPU
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	0	0	1	4	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	552	863
Insufficient Information	239	584
Perivalvular Leak	156	157
Malposition of Device	91	91
Fluid/Blood Leak	85	85
Difficult to Open or Close	46	46
Device Stenosis	43	43
Degraded	39	40
Burst Container or Vessel	38	39
Migration or Expulsion of Device	36	36
Gradient Increase	34	35
Difficult to Remove	33	33
Migration	29	29
Calcified	27	27
Central Regurgitation	22	22
Device Dislodged or Dislocated	20	20
Material Deformation	16	16
Material Split, Cut or Torn	15	15
Difficult or Delayed Positioning	14	14
Patient Device Interaction Problem	12	12
Material Separation	9	9
Material Rupture	9	9
Inflation Problem	9	9
Incomplete Coaptation	7	7
Difficult to Insert	7	7
Device Slipped	6	6
Detachment of Device or Device Component	6	6
Thickening of Material	5	5
Device Damaged by Another Device	4	4
Material Fragmentation	4	4
Material Integrity Problem	4	4
Difficult to Advance	4	4
Patient-Device Incompatibility	4	4
Physical Resistance/Sticking	4	4
Break	4	4
Positioning Failure	3	3
Deflation Problem	3	3
Retraction Problem	3	3
Entrapment of Device	3	3
Device-Device Incompatibility	3	3
Failure to Align	2	2
Fracture	2	2
Restricted Flow rate	2	2
Failure to Advance	2	2
Appropriate Term/Code Not Available	2	2
Off-Label Use	2	2
Leak/Splash	2	2
Unintended Collision	2	2
Therapeutic or Diagnostic Output Failure	1	3
Positioning Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	264	265
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	251	537
No Clinical Signs, Symptoms or Conditions	174	175
Mitral Valve Insufficiency/ Regurgitation	106	271
Obstruction/Occlusion	92	113
Cardiac Perforation	74	102
Heart Block	65	137
Thrombosis/Thrombus	57	73
Heart Failure/Congestive Heart Failure	55	55
Dyspnea	54	54
Ischemia Stroke	52	107
Foreign Body In Patient	23	23
Hemolysis	21	21
Stroke/CVA	15	15
Low Blood Pressure/ Hypotension	12	14
Vascular Dissection	11	23
Pericardial Effusion	11	11
Unspecified Vascular Problem	11	11
Foreign Body Embolism	11	11
Fatigue	10	10
Hemorrhage/Bleeding	9	13
Myocardial Infarction	9	9
Endocarditis	9	9
Cardiogenic Shock	9	9
Mitral Valve Stenosis	8	8
Hematoma	6	6
Perforation	6	6
Rupture	5	5
Stenosis	4	4
Perforation of Vessels	4	4
Atrial Fibrillation	4	4
Hemolytic Anemia	4	4
Aortic Valve Insufficiency/ Regurgitation	4	4
Retroperitoneal Hemorrhage	4	4
Chest Pain	4	4
Anemia	3	3
Cardiac Tamponade	3	3
Swelling/ Edema	2	2
Tachycardia	2	2
Pulmonary Edema	2	2
Calcium Deposits/Calcification	2	2
Injury	2	2
Ventricular Fibrillation	2	2
Cardiac Arrest	2	2
Valvular Insufficiency/ Regurgitation	2	2
Failure of Implant	2	2
Pleural Effusion	1	1
Paresthesia	1	1
Laceration(s)	1	1
Pain	1	1